PROSa: Burden and Medical Care of Sarcoma in Germany

Sponsor

Technische Universität Dresden (Other)

Overall Status

Completed

CT.gov ID

NCT03521531

Collaborator

(none)

1,309

Enrollment

Location

Actual Duration (Months)

29.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main objective of the study is to assess the treatment situation of sarcoma patients in Germany and to investigate their potential influence on Quality of Life (and other Patient Reported Outcomes) of the affected persons. Impaired quality of life domains and factors associated with it are to be identified.

To this end, a national network of sarcoma treatment specialists and a structure for patient recruitment will be established. This care network is intended to reflect the current situation of the treatment of sarcoma patients in Germany.

Condition or Disease	Intervention/Treatment	Phase
Sarcoma

Study Design

Study Type:

Observational

Actual Enrollment :

1309 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Burden and Medical Care of Sarcoma in Germany: Nationwide Cohort Study Focusing on Modifiable Determinants of Patient-Reported Outcome Measures in Sarcoma Patients

Actual Study Start Date :

Sep 30, 2017

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Jul 1, 2021

Outcome Measures

Primary Outcome Measures

Quality of Life - EORTC QLQ-C30 [1 year]
Measured with European Organization for Research and Treatment of Cancer Quality of Life Core Questionaire (EORTC QLQ-C30). The questionnaire consists of 30 questions assessing general quality of life issues of cancer patients. The EORTC QLQ-C30 includes 5 functional scales, measuring physical, role, emotional, cognitive, and social functioning, three multi-item symptom scales (fatigue, nausea/vomiting, and pain), and six single-item scales. High scores on the functional and global scales represent better quality of life. In contrast, high scores on the symptom scale indicate poor quality of life. Each instrument can reach values from 0-100.

Secondary Outcome Measures

Pain - Intensity (BPI) [1 year]
Measured with Brief Pain Inventory (BPI). The BPI gives two scores: a pain severity score and a pain interference score. The pain severity score is calculated from the four items about pain intensity. Each item is rated from 0, no pain, to 10, pain as bad as you can imagine, and contributes with the same weight to the final score, ranging from 0 to 40. The pain interference score consists of seven subitems rated from 0, does not interfere, to 10, completely interferes, and contributes with the same weight to the final score, ranging from 0 to 70.
Psychological Distress - PHQ-4 [1 year]
Measured with the Patients Health Questionnaire (PHQ-4). The PHQ-4 comprises 4 items and consists of the diagnostic core criteria for depression (PHQ-2) and for generalized anxiety disorders (GAD-2). Each instrument can reach values from 0-6. Higher Scores are indicating higher distress.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with sarcoma diagnosis according to International Classification of Diseases for Oncology (ICD-O) and World Health Organisation (WHO) classification

Exclusion Criteria:

not mentally able to fill out questionaires
not able to till out questionaires in German

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Dresden	Dresden	Saxony	Germany	01307

Sponsors and Collaborators

Technische Universität Dresden

Investigators

Principal Investigator: Markus Schuler, MD, Technical University Dresden, Medical Faculty
Principal Investigator: Jochen Schmitt, PhD, Technical University Dresden, Medical Faculty